- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05389332
A Mobile Health Intervention Among Hispanics
Developing and Testing a Mobile Health Intervention to Promote Sun Protection Behaviors and Skin Examination Among Hispanics
Hypothesis: More than 80% of the participants (n=40) will complete the intervention at three month (intervention completion) and the six month follow-up (retention rate as feasibility). More than 70% of the participants will report high overall study satisfaction (acceptability) with the intervention and study.
This pre-pilot will inform intervention and procedural refinements for the pilot.
Hypothesis: Participants who receive the intervention (n=57) will report more skin cancer-related preventive behaviors (e.g., mean of summed score of sun protection behaviors such as use of sunscreen, etc.) at three month and six month follow-up compared to those in the control condition (n=57, who will receive general information about physical activity and nutrition).
Study Overview
Status
Conditions
Detailed Description
Aim 1: The investigator will conduct individual interviews among key stakeholders such as health care providers and community leaders to plan a mobile skin cancer intervention among Hispanics. Data will be collected from individual interviews (n=10-12) among key stakeholders and triangulated with data from a funded pilot grant (focus groups and surveys with Hispanic community members) to gather information regarding Hispanics perceptions and behaviors related to skin cancer and suggestions for a WhatsApp intervention.
Aim 2: Employing a user-centered approach to develop a WhatsApp intervention to promote skin cancer risk-reduction behaviors among Hispanics and encourage engagement in the intervention. Use an iterative qualitative (focus groups with Hispanics, n=32; individual interviews with key stakeholders e.g., health care providers and community leaders, n=10-12) process to incorporate input from Hispanics and relevant stakeholders to develop a mobile WhatsApp intervention that is theory- and culturally-guided.
Aim 3: The investigators will evaluate the feasibility and acceptability of this mobile intervention in a single-arm pre-, post-test pilot study among at-risk Hispanics.
Aim 4: Refine the intervention and conduct a pilot RCT (n = 114) using this mobile program among Hispanics at risk for skin cancer and assess the preliminary effects of the mobile intervention at 3-month (intervention completion) and 6-month follow-ups.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zhaomeng Niu, PhD
- Phone Number: 509-339-3076
- Email: zhaomeng.niu@rutgers.edu
Study Locations
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Recruiting
- Rutgers Cancer Institute of New Jersey
-
Contact:
- Zhaomeng Niu, PhD
- Phone Number: 732-235-7921
- Email: zhaomeng.niu@rutgers.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Self-report as Hispanics
- 18 years or older
- No personal history of skin cancer
- Report more than one skin cancer risk factor
- Do not engage in sufficient sun protection behaviors
- Have not conducted a SSE in the past three months
- Own a smartphone and will be willing to use WhatsApp
Exclusion Criteria:
- Currently being treated for melanoma or nonmelanoma skin cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mobile skin cancer intervention
Conduct a pilot of the refined intervention among Hispanics to evaluate the preliminary efficacy of the user-centered mobile skin cancer intervention program.
|
With the insights from the community, the investigators will then develop the mobile intervention targeting Hispanics at risk for skin cancer to promote sun protection and SSE and get feedback to optimize the intervention.
After the random allocation participants will receive instructions on how to use WhatsApp and then the intervention.
They will receive WhatsApp messages about skin cancer for three months with optimal frequencies determined by prior aims and complete a post-intervention survey which contains the same questions in the pre-survey.
The pilot RCT will be conducted around the spring/summer of Year four of the R00 when UVR is generally the highest in the US.
The participants will be contacted at six months after the baseline survey to complete another survey similar to the post-intervention survey.
|
|
Active Comparator: Control group: physical activity and nutrition information
Participants will complete a baseline survey first; and then they will be randomly assigned into either the intervention group or the control group.
After the random allocation participants will receive instructions on how to use WhatsApp and then the intervention.
The participants will receive WhatsApp messages about skin cancer for three months with optimal frequencies determined by prior aims and complete a post-intervention survey which contains the same questions in the pre-survey.
The participants will be contacted at six months after the baseline survey to complete another survey similar to the post-intervention survey.
|
Content will be developed from established websites such as CDC's Division of Nutrition, Physical Activity and Obesity.
We selected these topics because they are also of concern among Hispanics and provide an unrelated attention control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sun protection behavior by self-report
Time Frame: The change is being assessed at baseline, three month and six month follow-up intervals
|
Mean score of use sunscreen with an SPF 30 or higher, seek shade, wear protective clothing, wear wide-brimmed hat, wear sunglasses
|
The change is being assessed at baseline, three month and six month follow-up intervals
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Seek shade behavior by self-report
Time Frame: The change is being assessed at baseline, three month and six month follow-up intervals
|
Seek shaded areas
|
The change is being assessed at baseline, three month and six month follow-up intervals
|
|
Wear protective clothing behavior by self-report
Time Frame: The change is being assessed at baseline, three month and six month follow-up intervals
|
Wear protective clothing
|
The change is being assessed at baseline, three month and six month follow-up intervals
|
|
Wear wide-brimmed hat behavior by self-report
Time Frame: The change is being assessed at baseline, three month and six month follow-up intervals
|
Waer a wide brim hat
|
The change is being assessed at baseline, three month and six month follow-up intervals
|
|
Wear sunglasses behavior by self-report
Time Frame: The change is being assessed at baseline, three month and six month follow-up intervals
|
Wear sunglasses
|
The change is being assessed at baseline, three month and six month follow-up intervals
|
|
Skin self-examination
Time Frame: Changes at baseline, three month and six month follow-up intervals
|
Skin examination by oneself
|
Changes at baseline, three month and six month follow-up intervals
|
|
Skin examination by a health care professional
Time Frame: Changes at baseline, three month and six month follow-up intervals
|
skin examination by a health care professional
|
Changes at baseline, three month and six month follow-up intervals
|
Collaborators and Investigators
Investigators
- Principal Investigator: Zhaomeng Niu, PhD, Rutgers Cancer Institute of New Jersey
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 132206
- Pro2022000533 (Other Identifier: Rutgers, The State University of New Jersey)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer of Skin
-
Washington University School of MedicineNational Institute for Biomedical Imaging and Bioengineering (NIBIB)CompletedBreast Cancer | Breast Tumors | Cancer of Breast | Malignant Neoplasm of Breast | Cancer of the BreastUnited States
-
Washington University School of MedicineTerminatedBreast Cancer | Cancer of Breast | Cancer of the BreastUnited States
-
Nuvation Bio Inc.WithdrawnBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Breast Carcinoma | Cancer of Breast | Malignant Tumor of Breast | Breast Tumor | Cancer of the BreastUnited States
-
Nina BhardwajOncovir, Inc.TerminatedMelanoma | Breast Cancer | Squamous Cell Carcinoma of the Head and Neck | Squamous Cell Carcinoma of the Skin | Sarcoma of the Skin | Basal Cell Cancer of the SkinUnited States
-
Brigham and Women's HospitalWithdrawnWound of Knee | Wound of Skin | Non-melanoma Skin Cancer | Skin Graft Complications | Wound of Lower LegUnited States
-
Verrica Pharmaceuticals Inc.Q2 Solutions; Instat Clinical Research; HeartcoR Solutions; Myonex; Vial Health Technology... and other collaboratorsCompletedCarcinoma | Skin Cancer | Basal Cell Carcinoma | Cancer of the Skin, Basal Cell | Cancer of the SkinUnited States
-
Washington University School of MedicineCompletedBreast Cancer | Breast Neoplasms | Cancer of Breast | Cancer of the BreastUnited States
-
Northwestern UniversityCompleted
-
BriaCell Therapeutics CorporationRecruitingBreast Cancer | Cancer of Breast | Malignant Tumor of Breast | Breast Tumor | Cancer of the Breast | Tumors, BreastUnited States
-
Assiut UniversityNot yet recruitingRole of MRI in Evaluation of Breast Cancer
Clinical Trials on Hispanics Skin Cancer intervention
-
Fox Chase Cancer CenterNational Cancer Institute (NCI)CompletedSkin NeoplasmsUnited States
-
Harvard School of Public Health (HSPH)American Academy of Dermatology (AAD)Completed
-
University of MichiganNational Institute of Neurological Disorders and Stroke (NINDS); Diocese of...Completed
-
Association of Dermatological Prevention, GermanyUniversity of Alberta; University of CalgaryUnknownMelanoma | Basal Cell Carcinoma | Squamous Cell Carcinoma | Skin TumorsCanada
-
Momentum DataPfizerCompletedVitiligo | Melanoma (Skin) | Actinic Keratoses | Basal Cell Carcinoma | Squamous Cell Carcinoma | Nonmelanoma Skin CancerUnited Kingdom
-
Melanoma and Skin Cancer Trials LimitedMonash UniversityCompletedSkin Cancer | Melanoma (Skin)Australia
-
National University Hospital, SingaporeNot yet recruitingSkin Cancer | Skin Cancer Prevention | Benign Skin Growth
-
University of UtahCompletedMelanoma | Young AdultUnited States
-
Northwestern UniversityCompleted
-
Ohio State University Comprehensive Cancer CenterBreast Cancer Research FoundationRecruiting